BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Nitrile Examination Glove

    Reg #: 3003011227 · FEI: 3003011227 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RUBBEREX ALLIANCE SDN. BHD.
    Registration Number
    3003011227
    FEI Number
    3003011227
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 138201 off 3/4 mile, Jalan Bercham, Kawasan Perindustrian Bercham
    City
    Ipoh Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K110102

    Owner / Operator

    Firm Name
    Rubberex Alliance Sdn. Bhd.
    Operator Number
    10051501
    Address
    Lot 138201 off 3/4 mile, Jalan Bercham, Kawasan Perindustrian Bercham
    City
    Ipoh
    State
    Perak
    Postal Code
    31400
    Country
    MY

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA

    Proprietary Names

    Nitrile Examination Glove

    Establishment Types

    Manufacture Medical Device